Single-Use Bioreactor Retention Assembly for High-Density Perfusion
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Solution Overview
Problem
The pharmaceutical industry lacks a disposable, pre-sterilized bioprocess system that integrates a single-use bioreactor, pump, and micro-organism retention filter for continuous processing at high cell density, which is essential for efficient production of biological materials, as existing reusable systems require costly and time-consuming steam sterilization and are prone to contamination.
Innovation Solution
A Disposable Bioprocess System comprising a Single-Use-Bioreactor, Single-Use-Pump, and Cross-Flow-Filter operating in Pulsating-Tangential-Flow mode, eliminating the need for steam sterilization and enabling continuous processing with reduced contamination risk, increased throughput, and simplified installation.
Engineering Contradictions & Design Principles
Engineering Contradiction Analysis
1Reliability
If reusable bioreactors are used, then equipment cost is reduced, but steam sterilization time and contamination risk increase
Solution Approach 1:
The patent applies the disposable principle by using single-use bioreactors made of flexible plastic material that are pre-sterilized and discarded after one use. This eliminates the need for time-consuming steam sterilization cycles and eliminates contamination risk from reusable equipment, directly resolving the technical contradiction between reliability and time loss.
2Loss of time
If disposable bioreactors are used, then sterilization time is reduced, but integration of pump and filter device increases system complexity
Solution Approach 1:
The patent merges the pump device and filter device into an integrated assembly that connects directly to the disposable bioreactor. The pump housing contains the filter device, and together they form a unified cell retention system that is simpler to implement than separate standalone components, resolving the contradiction between time reduction and system complexity.
3Productivity
If high cell density cultivation is implemented, then productivity increases, but contamination risk and sterilization requirements worsen
Solution Approach 1:
The disposable bioreactor system enables high cell density cultivation by providing a fresh, pre-sterilized environment for each run. The single-use nature ensures complete elimination of cross-contamination between batches, allowing aggressive high-density protocols without the contamination risks that would limit reusable systems, thus resolving the contradiction between productivity and reliability.
Applied Scientific Principles
This section explains which scientific principles are used to turn an abstract innovation direction into a practical engineering solution.
Function Achieved in This Case
The system provides cost-effective, contamination-free, and efficient continuous processing, allowing rapid evaluation of multiple cultures with higher productivity and reduced material and labor costs, while eliminating the need for traditional sterilization procedures.
Implementation Method 1
a conveying liquid pumping device for pumping the process liquid in one direction away from the interior process liquid volume
Implementation Method 2
a filter device separating the interior process liquid volume from the exterior facility area wherein means of liquid communication from the interior process liquid volume
Data Source
AI summary
A Disposable Bioprocess System of a Single-Use-Bioreactor, a Single-Use-Pump and a single-use micro-organism retention filter. Combined most suitable for cultivation of suspended micro-organisms in a liquid media at high micro-organism concentration in a perfusion mode continuous process for expression of biological material. The inlet port of the liquid Single-Use-Pump connects via a valve to the broth reservoir of the Single-Use-Bioreactor through a liquid conveying port. The outlet port of the liquid pumping Single-Use-Pump connects via a valve to a micro-organism retention filter. Also, a method for operating the sterile Disposable Bioprocess System in perfusion mode for continuously processing.